The NIH published the final rule, “Clinical Trials Registration and Results Information Submission,” on Sept. 21, 2016, with an effective date of Jan. 18, 2017.

The following are some of the rule’s highlights:

  • How does registration work? Studies are registered at ClinicalTrials.gov within 21 days of enrolling the first human subject.
  • Which trials are covered? All interventional clinical trials, involving FDA-regulated products, with one or more arms and with pre-specified outcome measures are subject to the rule. Expanded access use is not applicable.
  • Who submits information? One person, such as a principal investigator, is named the responsible party.
  • How are results submitted? Results are placed in a tabular format summarizing participant flow, demographic and baseline characteristics, primary and secondary outcomes, adverse event information, and any scientifically appropriate statistical tests. Plus, there must be a full protocol and statistical analysis plan. The results information must be submitted within one year of the study’s completion date.
  • What else is required? The final rule also requires submission of adverse events’ number and frequency, by arm or comparison group. It requires three tables of adverse event information, including one that summarizes all serious adverse events, another summarizing other AEs that happened with a frequency of 5% or more in any arm of the clinical trial, and a third that summarizes the all-cause mortality data by arm or group. The AE tables must include information about the events that occurred, whether they were anticipated, and it requires submission of the time frame for AE data collection.
  • What types of descriptions of results are submitted? The final rule does not require the submission of technical or non-technical narrative summaries of study results. NIH says in the final rule that summaries can lead to biased reporting, so they prefer results information to be presented in a tabular format.
  • Why make the change? NIH lists the benefits as follows:
    • The changes in submissions to ClinicalTrials.gov will help people find trials in which to enroll and ensure their participation is honored and trust enhanced by creating a public record of the trial and results.
    • Requiring publication of the results fulfills an obligation to trial participants from the research team.
    • It furthers the goal of ensuring research participation leads to accountability via the public reporting of information.
    • Having results available will assist people in making more informed decisions about participating in clinical trials.
  • What are the penalties of noncompliance? The following are the listed penalties:
    • NIH will publicly post notices of noncompliance in the data bank.
    • NIH will require report forms under certain grants to include a certification that required registration and results information submission are complete.
    • Federal agencies will need to verify compliance before future funding or continuation of funding.
    • The FDA has the authority to sanction responsible parties who fail to comply with the act.
    • Committing a prohibited act could subject the violator to criminal and/or civil penalties, including financial penalties.

For more information on the rule, visit: http://bit.ly/2cEpSMx.